Process Engineer

Job Title: Process Engineer
Location: Pomona, CA (In-office)
Position Type: Full-time
Vacancy Status: This position is vacant
AI Disclosure in Hiring: We use artificial intelligence to screen, assess and select applicants
Job Summary
The Process Engineer plays a critical role in the successful development, transfer, validation, and ongoing performance of pharmaceutical manufacturing processes. Reporting to the Validation Director, this position provides technical leadership across the product and process lifecycle, partnering closely with production, quality, validation, engineering, and other cross-functional teams to ensure processes are robust, scalable, compliant, and capable of consistently delivering high-quality products.
This role serves as a technical subject matter expert and thought leader, applying chemical engineering principles, Quality by Design (QbD), scientific understanding, and data-driven problem solving to improve process capability, reduce manufacturing risk, and support reliable commercial supply. The successful candidate will challenge the status quo, anticipate technical risks, and translate process knowledge into practical solutions that improve manufacturing performance, product quality, and business outcomes.
Role Specific Requirements
Technology Transfer and Process Scale-Up
Lead and execute technology transfer activities for commercial pharmaceutical products, including development of technology transfer protocols, reports, engineering batch protocols, and equipment compatibility assessments.
Coordinate pilot, engineering, and validation batches with production, quality, validation, engineering, and other cross-functional teams.
Develop and refine process flow diagrams, compounding instructions, and other technical documentation required to support commercial manufacturing.
Apply process understanding and QbD principles to ensure processes are scalable, reproducible, and capable of consistently meeting quality and manufacturing requirements.
Monitor process performance during scale-up and transfer activities and identify and resolve technical issues and process risks.
Process Validation and Lifecycle Management
Develop and execute process validation protocols and reports and support ongoing process verification activities.
Evaluate critical process parameters (CPPs), critical quality attributes (CQAs), and process performance data to assess process capability, robustness, and variability.
Conduct or support laboratory, pilot, engineering, and validation batches to generate process knowledge and support technical and regulatory requirements.
Use statistical analysis, process monitoring, and trending to identify emerging risks and opportunities to improve process control and performance.
Process Design, Risk Management and Compliance
Design and optimize manufacturing processes using sound chemical engineering principles and QbD methodology.
Conduct process risk assessments, including FMEA, and develop appropriate risk mitigation strategies.
Provide technical leadership for deviations, OOS investigations, root cause analysis, CAPAs, and Change Controls.
Review production batch records and manufacturing documentation to ensure alignment with approved process design and technical requirements.
Ensure process activities and recommendations comply with applicable GMP and regulatory requirements.
Equipment and Process Improvement
Identify and lead opportunities to improve process robustness, manufacturing efficiency, product quality, yield, and reliability.
Support the selection, acquisition, qualification, and implementation of new production equipment and technologies.
Lead or support equipment and process improvement initiatives, including the qualification and implementation of a new transfer pump for transferring product from the compounding tank to the IMA filling machine holding tank.
Use process data, engineering principles, and structured problem solving to identify sources of variability, reduce waste, and improve manufacturing performance.
Stay current with advances in pharmaceutical manufacturing, process engineering, and analytical approaches and apply relevant technologies and best practices to the organization.
Technical Leadership
Serve as a technical subject matter expert for assigned processes and build strong process understanding from development and technology transfer through commercial manufacturing.
Proactively identify technical risks and opportunities before they become manufacturing or quality issues.
Challenge existing processes and assumptions through data, scientific rationale, and sound engineering judgment.
Influence cross-functional teams through technical expertise, clear communication, and strong business judgment.
Mentor and develop junior engineers and contribute to building a culture of technical excellence, process ownership, and continuous improvement.
Additional Notes:
Working conditions: warehouse and production environments. Exposure to noise, chemicals, and machinery. PPE required in certain areas.
Physical demands: Walking, standing, occasional lifting (up to 50 pounds).
May require work outside regular hours or weekends.
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
Competencies Required for the Role
EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts whilst adapting to one’s audience. Exhibit willingness to listen, and show respect for oneself and others in interactions with others. Express oneself clearly in verbal and business writing.
FOSTERING COLLABORATION/TEAMWORK- is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.
ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this, supporting data-driven decision-making and strategic planning.
INITIATIVE - Identifying what needs to be done and doing it before being asked or before the situation requires it.
What We Are Looking For
Education:
Bachelor’s degree in Chemical Engineering with 4+ years of relevant experience in process engineering, process design, technology transfer, or validation within pharmaceutical manufacturing; or
Master’s degree in Engineering or a related discipline with 2+ years of relevant experience.
Experience:
Experience in pharmaceutical manufacturing, preferably within a GMP-regulated environment.
Experience with technology transfer, process design, scale-up, process validation, and continuous process improvement.
Experience with solid and/or semi-solid pharmaceutical manufacturing, including powders, pastes, and suspensions.
Experience applying Quality by Design (QbD), process risk assessment, and statistical approaches to manufacturing processes.
Skills:

Employment type
Full-time regular

Work arrangement
No